9 0 0 0 OA データインテグリティに関する規制対応の実践
- 著者
- 日本PDA製薬学会 電子記録・電子署名(ERES)委員会 データインテグリティ分科会 DI対応進め隊 阿部 いくみ 永田 久雄 荻原 健一 橋本 勝弘 加藤 尚志 橋本 剣一 杉浦 明子 普天間 竜治 高橋 潤 政井 宣興 武田 幸雄 櫻井 國幸 谷川 誠 前田 豊
- 出版者
- 一般社団法人日本PDA製薬学会
- 雑誌
- 日本PDA学術誌 GMPとバリデーション (ISSN:13444891)
- 巻号頁・発行日
- vol.24, no.1, pp.10-22, 2022 (Released:2022-06-22)
- 参考文献数
- 6
Although the regulatory requirements for data integrity are appropriately described in the relevant guidelines, the question can naturally be raised on how to afford the industry for their implementation. Hereof, it is worth advancing some proposals for concrete measures of data integrity remediation so that the industry could enforce the compliance without ambiguity in the above regulation specified by the authorities. In this study, we will introduce practical methods for time adjustment, hybrid, and audit trail review in the perspective of data integrity and attempt to share best practices for regulatory compliance regarding data integrity. The study will also detail all the points of time adjustment, hybrid, and audit trail review described at the “DI Remediation Practical Seminar” held in July 2021.
2 0 0 0 OA 新幹線高速化に伴う位置補正用地上子の応動距離拡大技術の開発
- 著者
- 橋本 直樹 薗部 正和 加藤 尚志 村上 徹
- 出版者
- 一般社団法人 日本機械学会
- 雑誌
- 日本機械学会論文集 (ISSN:21879761)
- 巻号頁・発行日
- pp.19-00095, (Released:2019-09-05)
- 参考文献数
- 11
JR east is developing a new ground coil to handle future speed increments in Shinkansen trains, as it is necessary to expand response distance of ground coils to cope with higher speeds. In addition, when lowering the mounting position of ground coils (as a measure against damage from falling ice), a need arises to adjust (expand) response distance. Therefore, in this research, we investigated measures to expand response distance of ground coils from the view point of feasibility, while maintaining compatibility with the current method. This research proved that an external power supply is effective for expanding response distance, so we have built a prototype ground coil with a built-in battery as a means of external power supply. The voltage detection control circuit supplies battery power only when electromagnetic waves are detected. The circuit configuration also uses a voltage induced by electromagnetic waves. This allows the battery to be used for more than 10 years. The high-speed rotation test confirmed that the prototype ground coil is capable of coping with 400 km/h even 300 mm from the ground coil and the on-board antenna. A falling-weight test confirmed that a new sturdier mounting base was capable of withstanding a load equivalent of 400 km/h. Since it was conformed that the prototype’s sufficient performance, we now plan to conduct a field test for practical use.
